Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Toxicology ×
3,029 results
481–504 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 01, 2005
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
K052017 · MKW
Dade Behring, Inc.
Toxicology · 37d
Cleared Aug 09, 2005
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
K052053 · DIF
Bio-Rad
Toxicology · 11d
Cleared Aug 08, 2005
HEMOGLOBIN A1C REAGENT SET
K051200 · LCP
Teco Diagnostics
Toxicology · 90d
Cleared Jul 28, 2005
QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
K042726 · LCM
Quest Diagnostics, Inc.
Toxicology · 300d
Cleared Jun 24, 2005
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA...
K050936 · LDJ
ACON Laboratories, Inc.
Toxicology · 71d
Cleared Jun 20, 2005
SENTINEL CHOLINESTERASE LIQUID
K051444 · DIH
Sentinel Ch. Srl
Toxicology · 18d
Cleared Jun 06, 2005
MAS IMMUNOSUPPRESSANT CONTROLS
K051074 · LAS
Microgenics Corp.
Toxicology · 40d
Cleared May 17, 2005
RANDOX BENZODIAZEPINE CLASS ASSAY
K050179 · JXM
Randox Laboratories, Ltd.
Toxicology · 111d
Cleared May 15, 2005
NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES,...
K050594 · LDJ
Nano-Ditech Co.
Toxicology · 68d
Cleared May 06, 2005
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
K050593 · DIS
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Apr 29, 2005
UCP RAPID DRUG SCREENING TESTS
K050540 · DKZ
Ucp Biosciences, Inc.
Toxicology · 58d
Cleared Apr 29, 2005
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
K050682 · DIF
Bio-Rad Laboratories, Inc.
Toxicology · 44d
Cleared Apr 18, 2005
ONTRAK TESTCARD 9
K050321 · DIO
Varian, Inc.
Toxicology · 68d
Cleared Apr 07, 2005
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
K042411 · NRP
Axis-Shield , Ltd.
Toxicology · 212d
Cleared Apr 01, 2005
QMS VANCOMYCIN
K050419 · LEH
Seradyn, Inc.
Toxicology · 42d
Cleared Mar 18, 2005
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
K050125 · JJY
More Diagnostics
Toxicology · 58d
Cleared Mar 15, 2005
CEDIA TACROLIMUS ASSAY
K050206 · MLM
Microgenics Corp.
Toxicology · 46d
Cleared Mar 11, 2005
ONLINE DAT PROPOXYPHENE PLUS
K043303 · JXN
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Mar 11, 2005
ON CALL MULTI-DRUG HOME TEST
K050050 · LDJ
ACON Laboratories, Inc.
Toxicology · 60d
Cleared Mar 04, 2005
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III
K050186 · DKZ
Ameditech, Inc.
Toxicology · 36d
Cleared Feb 28, 2005
TRIAGE TOX DRUG SCREEN
K043242 · LDP
Biosite Incorporated
Toxicology · 97d
Cleared Feb 25, 2005
ACON OXY II ONE STEP OXYCODONE TEST STRIP
K043507 · DJG
ACON Laboratories, Inc.
Toxicology · 67d
Cleared Feb 07, 2005
ONLINE DAT BENZODIAZEPINES PLUS
K043327 · JXM
Roche Diagnostics Corp.
Toxicology · 67d
Cleared Feb 07, 2005
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE...
K043386 · LEH
Ortho-Clinical Diagnostics, Inc.
Toxicology · 60d